Catheter apparatuses for a wide variety of medical and surgical applications are well known in the art. These catheter apparatuses commonly comprise a catheter handle at a proximal end of the catheter apparatus and one or more distally-extending members, which term is meant herein to include catheter tubes or shafts (defining one or a plurality of catheter lumens), guide wires, balloon members, actuation/control/pull wires and other types of catheter members that extend distally from the catheter handle, or from a given point within the catheter handle. The term distally-extending members specifically includes a plurality of distally-extending catheter shafts configured in annular or side-by-side relationship to one another, as well as articulation/control/pull wires used to actuate a function at the distal end of a catheter apparatus.
The catheter handle is intended to remain outside the body of a patient being treated and to serve as a base, a hand grip and a controller for a practitioner to manually or automatically manipulate the catheter apparatus and particularly the distally-extending members for treating the patient. In some applications, the catheter handle may also comprise one or more ports and related fluid tubes for introducing and/or removing fluids, for example to inflate/deflate a catheter balloon element, to flush an internal body location, to introduce drugs/medicines to an internal body site, to heat or cool parts of the apparatus and/or an internal body location, and other such applications.
Catheter members, such as catheter shafts and guide wires, extend distally from the catheter handle, and at least the distal portions of at least some of these catheter members are intended to extend internally into a patient's body during a medical or surgical treatment procedure. It is commonly desirable for a practitioner to manipulate portions of one or more of those distally-extending members from the catheter handle while the catheter apparatus is in use and while one or more of the distally-extending members is/are located at least in part inside the patient's body. Traditionally, catheter actuation handles are developed on an application-specific basis in which a particular handle design is utilized for a single set of end use conditions.
Catheter actuation handles are known in the art which are capable of realizing certain types of manipulation of distally-extending members. The prior art in this field includes the following patents, published patent applications, and technical and commercial publications: U.S. Pat. No. 7,488,337 (Apparatus and Methods for Bone, Tissue and Duct Dilatation); U.S. Pat. No. 7,503,914 (Dual-function Catheter Handle); U.S. Pat. Publ. No. US 2003/0236493 A1 (Articulating Handle for a Deflectable Catheter and Method Therefor); European Pat. No. EP1358903 B1 (Integrated Mechanical Handle with Quick Slide Mechanism); U.S. Pat. No. 6,171,277 (Bi-directional Control Handle for Steerable Catheter); U.S. Pat. No. 7,465,288 (Actuation Handle for a Catheter); U.S. Pat. No. 6,783,521 (Deflectable Catheter); U.S. Pat. No. 5,254,088 (Catheter Steering Mechanism); U.S. Pat. No. 5,391,172 (Stent Delivery System with Coaxial Catheter Handle); U.S. Pat. No. 8,062,345 (Delivery Systems for Delivering and Deploying Stent Grafts); U.S. Design Pat. No. D347,473 (Steerable Catheter Handle); European Pat. No. EP 1942975 A1 (Steerable Catheter Devices and Methods of Articulating Catheter Devices); European Pat. No. EP 1117341 A1 (Delivery Mechanism for Implantable Stent); St. Jude Agilis, “Steerable Introducer” (http://www.sjmprofessional.com/Products/US/EP-Access-Tools/Agilis-NxT-Steerable-Introducer.aspx); Medtronic Captivia, “Delivery System” (http://www.medtronic.com/for-healthcare-professionals/products-therapies/cardiovascular/aortic-stent-grafts/talent-thoracic-on-captivia/index.htm); Corevalve, “Delivery System” (http://www.medtronic.com/corevalve/ous/downloads/CoreValveProductBrochure.pdf); Bard, “Radia XT” (http://www.bardep.com/pdf/BAW04Z0650.pdf); BSC, “Blazer” (http://www.bostonscientific.com/templatedata/imports/collateral/Electrophysiology/crr_com/EP T-10874-01-BlazerPrimeBroc_DEC-2010.pdf); IDev, “Supera Delivery System” (http://www.idevmd.com/deliverySystem.html).
The complete disclosure of each of the above-listed patents, published patent applications and technical and commercial publications is incorporated herein by reference in their entireties.
These prior art approaches to catheter actuation handles, however, are deficient in one or more respects, such as being awkward to use, or being limited in their capability of achieving concurrent and, possibly, different types of manipulation of different catheter members, or requiring costly and time-consuming customized design, fabrication and assembly for a particular application. The prior art in this field does not teach a modular catheter actuation handle comprised of a standardized and, at least in part, interchangeable set of component parts, that can be configured or reconfigured relatively quickly to adapt the catheter handle to a particular combination of desired manipulation operations on the distally-extending members.
Furthermore, several types of manipulation of single or multiple distally-extending members may be desirable but not readily achievable with known catheter actuation handle technology, including such operations as: (1) “full-stroke” translation (axial movement) of one catheter shaft relative to one or more other catheter shafts or other catheter members; (2) articulation (bending) of a stationary outer catheter shaft with concurrent translation of an inner catheter shaft; (3) translation of an outer catheter shaft with concurrent articulation of a stationary inner catheter shaft; (4) independent translation, articulation or rotation of one catheter shaft relative to one or more other catheter shafts; and, (5) independent translation, articulation or rotation of two out of three or more catheter shafts relative to a third stationary catheter shaft.
The present invention enables one to realize types of manipulations of distally-extending members, including multiple manipulations and/or combinations of manipulations, that were realizable only with a specially designed, single-purpose catheter handle apparatus.